MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIVERSAL PIN DRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 71513331

Device Problems Material Fragmentation (1261); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2021

Event Type  malfunction  

Event Description

It was reported that, during a tka surgery, two (2) universal pin drivers failed to hold the profix bone spikes, both cracked while the surgeon placed the pins into the a/p block.Pieces of the devices were retrieved but it is unknown how.Surgery was resumed, without any delay, with a back-up device.Patient was not injured as consequence of this problem.Also, a genesis ii posterior stabilized constrained housing reamer dome have become dull and did not ream well.Surgery was resumed, without any delay, with the same device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNIVERSAL PIN DRIVER
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12307366
• MDR Text Key: 266015461
• Report Number: 1020279-2021-06289
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03596010589064
• UDI-Public: 03596010589064
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71513331
• Device Catalogue Number: 71513331
• Device Lot Number: 18BM18534
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1